,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #abji  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #aa1 #bjai ,mr4 
,cassidy 7= himself & ,mr4 ,durb97      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to    
approval ( abbreviat$ new drug          
applications4  #a4 ,%ort title  ,?is    
,act may be cit$ z ! ,re=m+ ,ev]gre5+ & 
,manipulation t ,ext5ds ,drug ,ye>s ,act
 or ! ,,rem$y ,act4  #b4 ,am5dm5ts to   
,,&a approval provision  7a7 ,9 g5]al   
,section #eje ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is 
am5d$--  7#a7 9 subsection 7c77#c77;,c71
 by ins]t+ 9 ! case ( a c]tification )  
respect to a pat5t t claims a drug      
sub/ance 7& n 9 ! case ( a c]tification 
) respect to a pat5t t claims a drug    
product or me?od ( use = a drug1 except 
t1 9 ! case ( a pat5t t claims a drug   
sub/ance & a drug product or me?od (    

use1 ?is subp>agraph %all apply1 b only 
to ! ext5t ! pat5t claims a drug        
sub/ance71 aft] imm$iately unless12 &   
7#b7 9 subsection 7j77#e77;,b77iii71 by 
ins]t+ 9 ! case ( a c]tification )      
respect to a pat5t t claims a drug      
sub/ance 7& n 9 ! case ( a c]tification 
) respect to a pat5t t claims a drug    
product or me?od ( use = a drug1 except 
t1 9 ! case ( a pat5t t claims a drug   
sub/ance & a drug product or me?od (    
use1 ?is clause %all apply1 b only to ! 
ext5t ! pat5t claims a drug sub/ance71  
aft] imm$iately unless14  7b7 ,orange   
book updates ) respect to invalidat$    
pat5ts  7#a7 ,9 g5]al ,section          
#eje7;j77#g77;,a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#g77;,a77 is am5d$ by add+ at !
 end ! foll[+3  7iv7 ,9 ! case ( a li/$ 
drug = :i* ! li/ "u clause 7i7 includes 
a pat5t t claims ! drug or a use = su*  
drug1 & :]e ! ,"u ,secret>y ( ,comm]ce =
 ,intellectual ,prop]ty & ,director ( ! 
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice 

has cancell$ any claim ( ! pat5t relat+ 
to su* drug or su* use pursuant to a    
det]m9ation by ! ,pat5t ,trial & ,appeal
 ,bo>d 9 an int] p>tes review conduct$  
"u *apt] #ca ( title #ce1 ,unit$ ,/ates 
,code1 or a po/-grant review conduct$ "u
 *apt] #cb ( t title1 & any su*         
cancellation1 if appeal$1 has be5 upheld
 ^u appeal1 ! hold] ( ! applicable      
approv$ application %all notify !       
,secret>y ( su* cancellation1 & !       
revisions requir$ "u clause 7iii7 %all  
include /rik+ ! pat5t f ! li/ ) respect 
to su* drug4  4  7#b7 ,no effect on fir/
 applicant exclusivity p]iod ,section   
#eje7;j77#e77;,b77iv77,i7 is am5d$ by   
add+ at ! end ! foll[+3 ,?is subclause  
%all apply ev5 if a pat5t is /rick5 f ! 
li/ "u p>agraph 7#g77;,a71 pursuant to !
 second s5t5ce ( clause 7iii7 ( su*     
p>agraph1 provid$ t1 at ! "t t ! fir/   
applicant submitt$ an application "u ?is
 subsection conta9+ a c]tification      
describ$ 9 p>agraph                     
7#b77;,a77vii77,,iv71 ! pat5t t 0 !     

subject ( su* c]tification 0 includ$ 9  
su* li/ ) respect to ! li/$ drug44